Tag: Drug Approvals
Three FDA Advisers Quit Over Agency Approval of Aduhelm
Several experts have said the available evidence about Aduhelm raises significant doubts about its effectiveness
FDA Approves Aduhelm for Alzheimer Disease
Agency says it has granted approval on the condition that drug maker Biogen conduct a new clinical trial
Farxiga Approved to Reduce Risk for CKD Progression
SGLT2 inhibitor approved for patients with CKD to prevent kidney function decline, kidney failure, CV death, hospitalization for heart failure
FDA Approves Higher-Dose Naloxone Hydrochloride Nasal Spray
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses
FDA Approves Immunotherapy for dMMR Endometrial Cancer
Jemperli approved for dMMR endometrial cancer that progressed after platinum-containing chemotherapy treatment
Opdivo Plus Chemotherapy Approved for Treatment of Gastric Cancer
FDA granted Opdivo first approval of immunotherapy for first-line treatment of advanced or metastatic gastric cancer
FDA Approves Therapy to Protect Bone Marrow Cells From Effects of Chemotherapy
Cosela reduces the frequency of bone marrow suppression caused by chemotherapy for extensive-stage small cell lung cancer
Combination Monoclonal Antibody Treatment Authorized for COVID-19
EUA issued for combination of bamlanivimab and etesevimab in patients with mild-to-moderate COVID-19 at high risk for disease progression
Breyanzi Approved for Certain Types of Large B-Cell Lymphoma
The CAR T cell therapy OK'd for patients who have not responded to or have relapsed after receiving two or more other systemic treatments
FDA Approves First Monthly Injectable Regimen for HIV
Trials show virologic suppression in comparable numbers of patients receiving monthly injection with Cabenuva, daily current antiretroviral regimen
